MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex duodenal stent was used in the gastric antrum during a digestive stent implantation procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat a 2cm stricture in the gastric antrum due to stomach cancer and to clear the route for an endoscopic retrograde cholangiopancreatography (ercp) planned for (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.There were no issues reported during the initial stent placement.On (b)(6) 2015 the patient underwent the planned endoscopic retrograde cholangiopancreatography (ercp).The following day, on (b)(6) 2015, the patient experienced abdominal pain and a ct scan was performed which confirmed a perforation of the gastric antrum located in the middle part of the stent (tumor site).A stent-in-stent procedure was performed to cover up the perforated area with a duodenal covered stent and the patient was given antibiotics.The patient's current condition is stable.In the physician's assessment, the perforation might have occurred because of excessive stress when the endoscope passed through the stent during the ercp procedure performed on (b)(6) 2015.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5169925
• MDR Text Key: 29003886
• Report Number: 3005099803-2015-02983
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2017
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0018209410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 55